Volumetric Modulated Arc Therapy (VMAT) for Brain Metastases
|ClinicalTrials.gov Identifier: NCT01046123|
Recruitment Status : Active, not recruiting
First Posted : January 11, 2010
Last Update Posted : October 20, 2016
Radiotherapy to the whole brain is standard treatment for cancer that has spread to the brain (brain metastases) as it treats both the metastases that can be seen on scans and the brain metastases that are too small to be seen on scans.
This study will use a novel radiotherapy technique, called volumetric modulated arc therapy (VMAT), to treat patients with brain metastases. This technique allows delivery of both a standard radiation dose to the whole brain as well as a higher radiation dose to the brain metastases at the same time.
The study will assess the effectiveness of using VMAT in treating brain metastases, and examine its potential side-effects.
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Radiation: whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy||Phase 2|
This is a Phase II prospective clinical trial. Following registration, patients will be required to undertake a baseline questionnaire assessment of daily living activities using the Modified Barthel's index, as well as cognitive assessment using MMSE.
Patients will undergo MRI scan of the brain for radiotherapy planning purposes. During radiotherapy planning and for each of the five radiotherapy fractions, patients will be immobilised in a custom fitted stereotactic mask system, to minimise head movement. During treatment, patients will have daily online setup corrections to ensure treatment accuracy.
Patients will be treated with WBRT/SIB using VMAT, delivering a total of 20 Gy in 5 fractions to the whole brain and 50Gy in 5 fractions to the brain metastases, delivered once daily on working days. Anti-nausea and anti-inflammatory medication will be prescribed to minimise acute toxicity.
Following therapy completion, patients will be seen every 3 months for the 1st year, then every 6 months thereafter. At each clinic visit, clinicians or study investigators will monitor for toxicity from therapy, document neurologic symptoms and signs and performance status as well as Modified Barthel's index and cognitive assessment.
Patients will have contrast-enhanced MRI brain at 3 months and 1 year, and contrast-enhanced CT brain at 6 months and 9 months in the first year and every 6 months after the first year. Serum creatinine levels will be done prior to each scan to ensure safety of intravenous contrast administration.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Whole Brain Radiotherapy With Simultaneous Integrated Boost Using Volumetric Modulated Arc Therapy for One to Ten Brain Metastases|
|Study Start Date :||January 2010|
|Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||December 2019|
Experimental: Whole brain radiotherapy
whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy
Radiation: whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy
Patients will be treated with WBRT/SIB using VMAT, delivering a total of 20 Gy in 5 fractions to the whole brain and 50Gy in 5 fractions to the brain metastases, delivered once daily on working days.
- 3 month treatment response of metastases evaluated using contrast-enhanced MRI scan of brain [ Time Frame: 3 months post treatment ]
- 1-year local control of treated metastases evaluated with contrast-enhanced MRI scan of brain [ Time Frame: 1 year post-treatment ]
- 1-year brain control of metastases evaluated with contrast-enhanced MRI scan of brain [ Time Frame: 1 year post-treatment ]
- Median survival [ Time Frame: No time frame ]
- Both acute neurological toxicity (within 3 months of treatment) and late neurological toxicity (beyond 3 months of treatment [ Time Frame: 3 months and beyond ]
- Time to decline in activities of daily living evaluated using the Modified Barthel index [ Time Frame: No time frame ]
- Time to decline in cognition evaluated with the Mini-mental state examination [ Time Frame: No time frame ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046123
|Canada, British Columbia|
|BC Cancer Agency - Vancouver Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Principal Investigator:||Alan Nichol, MD||British Columbia Cancer Agency|